Developer of genetically engineered salmon eyes Canadian regulators

OTTAWA: The developer of genetically engineered salmon for human
consumption is now setting its sights on Health Canada, after U.S.
regulators on Wednesday announced their review of AquaBounty
Technologies Inc.’s historic application for the American market is
nearly complete.

The U.S. Food and Drug Administration published details of the last
stages of its review for AquAdvantage Salmon, made from eggs produced
in a hatchery in Prince Edward Island. The genetically engineered fish
can grow at twice the normal rate, and the company, headquartered in
Massachusetts with Canadian operations in P.E.I. and Newfoundland and
Labrador, has been trying for a decade to get approval to become the
first genetically engineered animal that people would eat.

After the FDA’s special veterinary medicine committee convenes next
month to consider issues of animal health, food safety, environmental
concerns, and data validating the claim that AquAdvantage Salmon grow
faster than their conventionally bred counterparts, the Center for
Food Safety and Applied Nutrition will lead a public hearing to
consider legal issues around labelling, should the AquAdvantage Salmon
be approved in the next few months.

“We’re very encouraged,” AquaBounty president and chief executive
officer Ronald Stotish said in an interview Wednesday of the FDA review.“This is the first food animal, we hope the world’s first FDA-approved
genetically modified food animal.”

The company, meanwhile, has started the process to gain approval from
Health Canada to sell its genetically engineered Atlantic salmon in
Canada as a novel food.

“We are applying in Canada. It’s in the early stages,” said Stotish.
“We’re very interested because of our strong presence in Canada.”

AquaBounty’s hatchery in P.E.I. uses technology developed by
scientists at Memorial University supported by Canadian granting
councils, “so we’re very much a Canadian company as well,” said Stotish.

That’s why opponent Lucy Sharratt, co-ordinator of the Canadian
Biotechnology Action Network, said the federal government needs to
show some leadership on the file and shut the door to genetically
engineered salmon.

“Regardless of any protections that are discussed, GE salmon represent
a threat to wild salmon. And the health questions about GE animals for
human consumption are huge, really complex and they’re unanswered. Our
government hasn’t even figured out how to regulate, to assess the
safety of GE animals, so consumers don’t even have a starting point to
think about having confidence in this really grotesque idea of GE
animals in the food system. They’re unnecessary in the first instance
and second, they’re very, very dangerous,” said Sharratt.

“They’re trying to force the door open in Canada by getting approval
in the U.S.,” Sharratt added, referring to AquaBounty. “Health Canada
has already said that it’s not developing regulations to address GE
animals right now, that it accepts the approach of the FDA.”

Stotish, who said the two regulatory processes are separate, defended
his product.

“We know we have a safe product with a lot of attributes that will
attractive to consumers and address some of the problems associated
with production of food in the future, so we’re encouraged by these
developments,” Stotish said of the progress at the FDA.

Health Canada is reviewing a second application to permit a
genetically engineered animal for human consumption. The so-called
“Enviropigs,”
developed by University of Guelph scientists as the world’s first
transgenic animal created to solve an environmental problem, were
created in 1999 with a snippet of mouse DNA introduced into their
chromosomes.

Guelph last year submitted an application to Health Canada, seeking a
government declaration that its transgenic pig is fit for human
consumption.

Earlier this year, Environment Canada determined that the pigs are not
toxic to the environment under the Canadian Environmental Protection
Act, the first regulatory hurdle to get the pigs to market.

“It’s definitely urgent. The GE salmon and the Enviropig are in
competition . . . to be approved for food in the world. Both of these
are products of university research in Canada, so it really matters
what Canada decides,” said Sharratt.